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1. JP2018048162 - REMOVAL OF PROTEIN AGGREGATES FROM BIOPHARMACEUTICAL PREPARATIONS IN FLOW-THROUGH MODE

Office
Japon
Numéro de la demande 2017200909
Date de la demande 17.10.2017
Numéro de publication 2018048162
Date de publication 29.03.2018
Numéro de délivrance 6580650
Date de délivrance 06.09.2019
Type de publication B2
CIB
C07K 1/16
CCHIMIE; MÉTALLURGIE
07CHIMIE ORGANIQUE
KPEPTIDES
1Procédés généraux de préparation de peptides
14Extraction; Séparation; Purification
16par chromatographie
C08F 255/02
CCHIMIE; MÉTALLURGIE
08COMPOSÉS MACROMOLÉCULAIRES ORGANIQUES; LEUR PRÉPARATION OU LEUR MISE EN UVRE CHIMIQUE; COMPOSITIONS À BASE DE COMPOSÉS MACROMOLÉCULAIRES
FCOMPOSÉS MACROMOLÉCULAIRES OBTENUS PAR DES RÉACTIONS FAISANT INTERVENIR UNIQUEMENT DES LIAISONS NON SATURÉES CARBONE-CARBONE
255Composés macromoléculaires obtenus par polymérisation de monomères sur des polymères d'hydrocarbures tels que définis dans le groupe C08F10/161
02sur des polymères d'oléfines contenant deux ou trois atomes de carbone
CPC
B01D 15/362
BPERFORMING OPERATIONS; TRANSPORTING
01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
DSEPARATION
15Separating processes involving the treatment of liquids with solid sorbents
08Selective adsorption, e.g. chromatography
26characterised by the separation mechanism
36involving ionic interaction
361Ion-exchange
362Cation-exchange
C07K 1/165
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
KPEPTIDES
1General methods for the preparation of peptides ; , i.e. processes for the organic chemical preparation of peptides or proteins of any length
14Extraction; Separation; Purification
16by chromatography
165mixed-mode chromatography
C07K 1/18
CCHEMISTRY; METALLURGY
07ORGANIC CHEMISTRY
KPEPTIDES
1General methods for the preparation of peptides ; , i.e. processes for the organic chemical preparation of peptides or proteins of any length
14Extraction; Separation; Purification
16by chromatography
18Ion-exchange chromatography
B01D 15/363
BPERFORMING OPERATIONS; TRANSPORTING
01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
DSEPARATION
15Separating processes involving the treatment of liquids with solid sorbents
08Selective adsorption, e.g. chromatography
26characterised by the separation mechanism
36involving ionic interaction
361Ion-exchange
363Anion-exchange
B01D 15/3809
BPERFORMING OPERATIONS; TRANSPORTING
01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
DSEPARATION
15Separating processes involving the treatment of liquids with solid sorbents
08Selective adsorption, e.g. chromatography
26characterised by the separation mechanism
38involving specific interaction not covered by one or more of groups B01D15/265 - B01D15/36
3804Affinity chromatography
3809of the antigen-antibody type, e.g. protein A, G, L chromatography
B01J 39/20
BPERFORMING OPERATIONS; TRANSPORTING
01PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
JCHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
39Cation exchange; Use of material as cation exchangers; Treatment of material for improving the cation exchange properties
08Use of material as cation exchangers; Treatment of material for improving the cation exchange properties
16Organic material
18Macromolecular compounds
20obtained by reactions only involving unsaturated carbon-to-carbon bonds
Déposants MERCK PATENT GMBH
メルク パテント ゲーエムベーハー
Inventeurs MIKHAIL KOZLOV
ミハイル・コズロフ
CATALDO WILLIAM
ウイリアム・カタルド
POTTY AJISH
アジシユ・ポテイ
GALIPEAU KEVIN
ケビン・ガリポー
JAMES HAMZIK
ジエームズ・ハムジク
UMANA JOAQUIN
ホアキン・ウマーナ
LARS PEECK
ラルス・ピーク
Mandataires 特許業務法人川口國際特許事務所
Données relatives à la priorité 61/609,533 12.03.2012 US
61/666,578 29.06.2012 US
Titre
(EN) REMOVAL OF PROTEIN AGGREGATES FROM BIOPHARMACEUTICAL PREPARATIONS IN FLOW-THROUGH MODE
(JA) フロースルー式での生物製剤からのタンパク質凝集体の除去
Abrégé
(EN)

PROBLEM TO BE SOLVED: To provide products of interest from a protein aggregate in a biopharmaceutical composition, for example, a novel and improved composition for separating a therapeutic antibody or monomeric protein; and to provide flow-through methods using such compositions.

SOLUTION: Disclosed is a flow-through chromatography method which comprises contacting a sample with a solid support comprising a polymer attached thereto, the polymer comprising one or more cation exchange binding groups and one or more dimethylacrylamide groups. The dimethylacrylamide groups are present in a greater number than one or more cation exchange binding groups, thereby separating the monomeric protein of interest from a protein aggregate. The solid support is selected from a chromatographic resin, a membrane, a porous bead, a porous monolith, a winged fiber, a woven cloth, and a nonwoven cloth. One or more cation exchange groups are selected from a sulfonic acid group, a sulfuric acid group, a phosphonic acid group, a phosphate group, and a carboxyl group.

SELECTED DRAWING: Figure 2A

COPYRIGHT: (C)2018,JPO&INPIT


(JA)

【課題】生物医薬組成物中のタンパク質凝集体から対象の生成物、例えば、治療用抗体又は単量体タンパク質を分離する為の新規且つ改善された組成物並びにそのような組成物を用いるフロースルー方法の提供。
【解決手段】試料を、そこに付着するポリマーを含む固体担体と接触させるステップを含み、ポリマーは、1つ又は複数の陽イオン交換結合基及び1つ又は複数のジメチルアクリルアミド基を含み、ジメチルアクリルアミド基は、1つ又は複数の陽イオン交換結合基よりも多い数で存在し、それにより、タンパク質凝集体から対象の単量体タンパク質を分離する、フロースルークロマトグラフィー方法。固体担体がクロマトグラフィー樹脂、膜、多孔質ビーズ、多孔性モノリス、翼状繊維、織布および不織布から選択され、1つ又は複数の陽イオン交換基がスルホン酸基、硫酸基、ホスホン酸基、リン酸基およびカルボキシル基から選択される、方法。
【選択図】図2A